Senior GMP Quality Leader: CMC & CDMO Oversight

Generate Biomedicines; Somerville (MA); On-site; USD 210,000 - 290,000; Full time

Job summary

Generate Biomedicines seeks a Senior Director of GMP Quality to build and maintain fit-for-purpose quality systems, overseeing CDMOs and contract labs to ensure regulatory and company requirements are met. This hands-on leader partners with Technical Operations, Regulatory Affairs, Clinical Development, and Supply Chain from development through commercialization.

You will drive risk-based quality frameworks, lifecycle management, and quality oversight across CMC, analytical strategies, and

Qualifications

• Extensive GxP quality leadership experience supporting biologics development.
• Strong knowledge of quality systems, including deviations, investigations, CAPAs, change controls, OOS/OOT management, data integrity, and inspection readiness.
• Experience providing quality oversight across preclinical, CMC, clinical manufacturing, QC, supply chain, and product lifecycle activities.
• Significant quality oversight experience working with CDMOs, CROs, contract testing laboratories, suppliers, and other external partners.
• Experience leading audits, quality agreements, partner performance management, investigations, remediation, and risk mitigation.
• Demonstrated success supporting regulatory submissions, health authority interactions, inspections, and responses to regulatory findings.

Responsibilities

• Establish and maintain a scalable GxP Quality framework covering analytical testing, manufacturing, technology transfer, validation, product lifecycle management, and regulatory commitments.
• Provide independent, phase-appropriate Quality oversight of CMC and analytical strategies, including control strategies, CQAs, CPPs, specifications, method development and validation, comparability, stability, reference standards, and lifecycle management.
• Lead Generate’s CMC Quality relationships with CDMOs, contract testing laboratories, and other technical partners, including qualification, quality agreements, governance, performance management, audits, and issue escalation.
• Provide Quality oversight of outsourced development, manufacturing, testing, packaging, and storage activities, ensuring compliant and timely execution of clinical supply, GMP release, stability, validation, and lifecycle management.
• Provide Quality leadership across technology transfer, scale‑up, process characterization, manufacturing changes, comparability, continued process verification, and other lifecycle activities.
• Review and approve key GMP and regulatory documentation, and provide quality leadership for manufacturing campaigns, batch release, deviations, investigations, CAPAs, change controls, product disposition, and other significant quality events.
• Drive product quality risk management, audit and inspection readiness, data integrity, computerized systems compliance, and alignment with global regulatory expectations.

Skills

GMP leadership

Quality leadership

Regulatory readiness

Data integrity

Risk management

Audits

Education

Bachelor's degree in science

Tools

GxP systems

Job description

Generate Biomedicines seeks a Senior Director of GMP Quality to build and maintain fit-for-purpose quality systems, overseeing CDMOs and contract labs to ensure regulatory and company requirements are met. This hands-on leader partners with Technical Operations, Regulatory Affairs, Clinical Development, and Supply Chain from development through commercialization.

You will drive risk-based quality frameworks, lifecycle management, and quality oversight across CMC, analytical strategies, and